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Taltz ® (ixekizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Medication for injection site reactions with Taltz® (ixekizumab)
The prescribing physician decides whether to medicate a patient in order to prevent or reduce allergic/hypersensitivity reactions.
Table of Contents
- Prevention of injection site reactions in the ixekizumab clinical trials
- How many patients in the clinical trials used premedications?
- Treatment of injection site reactions in the psoriasis clinical trials
- Does an injection site reaction need treatment in any case?
How common are injection site reactions?
Injection site reactions (ISR) were one of the most frequently reported adverse events (AE) with ixekizumab. The most frequent injection site reactions observed were erythema and pain.1
Is it necessary to discontinue ixekizumab because of injection site reactions?
ISRs were predominantly mild to moderate in severity and did not lead to discontinuation of ixekizumab.1
Premedication before injecting ixekizumab
Prevention of injection site reactions in the ixekizumab clinical trials
According to the protocols for
- psoriatic arthritis, and
- axial spondyloarthritis (axSpA), including ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA) and nonradiographic axial spondyloarthritis (nr-axSpA) trials,
if a patient experienced an acute allergic/hypersensitivity reaction after injection of investigational product, consideration for any premedication for future injections was agreed upon between the investigator and sponsor and/or its designee. Examples of potential allergic/hypersensitivity reactions that might merit premedication included
- mild-to-moderate skin rashes
- mild-to-moderate generalized pruritus or urticaria, and
- mild-to-moderate injection site reactions (ISRs) (eg, injection-site erythema, injection-site pruritus, etc.).2,3
Medications considered appropriate for premedication included but were not restricted to
- acetaminophen/paracetamol up to 1000 mg and
- antihistamines (for example, oral diphenhydramine 50 mg), given 30 to 60 minutes prior to investigational product injection.
- Patients were permitted to self-premedicate at home prior to administration of investigational product as directed by the investigator.2,3
Please note that ixekizumab is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients.1
How many patients in the clinical trials used premedications?
Of patients experiencing an ISR during the induction period of UNCOVER-1, -2, and -3, one patient who received ixekizumab (original formulation) used premedication for ISR when taking future injections.3
No patients who received ixekizumab during the 24-week double-blind treatment periods of SPIRIT-P1 and SPIRIT-P2 used premedication for ISR with future injections.3
No analysis has been conducted on patients who used premedication for ISR with future injections in axSpA trials.
Medication after ixekizumab injection
There is no specific recommendation for the treatment of Injection Site Reactions (ISR). But we hope the following information will help make a clinical decision.
Treatment of injection site reactions in the psoriasis clinical trials
In the ixekizumab trials, patients were allowed to use over-the-counter
- topical antihistamines and
- topical steroids.2
Among those who received treatment, the majority received antihistamines.4
Total patients with treatment-emergent ISR (N=1096)
Patients with at least 1 concomitant medication for indication of ISR
Patients treated with concomitant medications for indication of ISR (N=55)a
Abbreviation: ISR = injection site reaction.
aConcomitant medications listed reflect those reported as ISR for indication in at least 5 patients. Values reflect percentages of patients who reported use of at least one concomitant medication for ISR. Patients may have received greater than one concomitant medication for ISR.
bDesloratidine (n=3), loratidine (n=3), loratidine with pseudoephedrine (n=1).
cTopical corticosteroids across potency classes were allowed during the open-label treatment period in the UNCOVER studies for any indication for use. The topical corticosteroids referenced in this table given for the indication of ISR (n=1 for each medication listed) consist of: Potent - betamethasone valerate, fluocinolone acetonide, fluocinonide, methylprednisolone aceponate; Very potent - clobetasol propionate; Weak - hydrocortisone.
dDimetindene maleate (n=3), diphenhydramine hydrochloride (n=1), fenistil (n=1).
Does an injection site reaction need treatment in any case?
Concomitant medication to treat injection site reactions (ISR) was uncommonly used. It was used in
- 1.5% of patients treated with ixekizumab every 2 weeks (Q2W) and
- 1.6% of patients treated with etanercept during the first 12 weeks of the UNCOVER studies.4
In an analysis of patients across 18 psoriasis trials, 55 of the 1096 patients (5.0%) who experienced a treatment-emergent ISR were reported to have received a concomitant medication to treat the ISR.3 summarizes the concomitant medications used to treat ISRs in the all psoriasis ixekizumab safety population (N=7088 total patients) across 18 clinical trials in adult and pediatric patients with psoriasis.3
How to choose the injection site
The package leaflet and the user manual give further comprehensive instructions for administration.5-7
Citrate-free ixekizumab formulation
The information regarding injection site reactions (ISRs) and concomitant treatment for ISRs included in this response is from trials using the commercial formulation of ixekizumab. No information is available regarding concomitant medications used to treat ISRs in studies of the citrate-free formulation of ixekizumab.
The information included in this response is specific to medications that were used to treat ISRs that were reported from an overall psoriasis safety database across 18 clinical trials in adult and pediatric patients. The information provided is for reference only and does not constitute a treatment recommendation. Health care decisions to use concomitant medications in patients who experience ISRs with the use of ixekizumab should be based on the best clinical judgment of the prescribing health care practitioner.
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
2Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Shear NH, Paul C, Blauvelt A, et al. Safety and tolerability of ixekizumab: integrated analysis of injection-site reactions from 11 clinical trials. J Drugs Dermatol. 2018;17(2):200-206. http://jddonline.com/articles/dermatology/S1545961618P0200X
5Taltz 80 mg solution for injection in pre-filled syringe [Instructions for use]. Eli Lilly and Company (Ireland) Limited, Ireland
6Taltz [patient information leaflet]. Eli Lilly and Company (Ireland) Limited, Ireland
7Taltz 80 mg solution for injection in pre-filled pen [Instructions for use]. Eli Lilly and Company (Ireland) Limited, Ireland
Date of Last Review: 07 August 2023